AccessGUDID - DEVICE: Identify® Diagnostics Drug Test Cups (10850013035219)

GUDID

Device Identifier (DI) Information

Brand Name: Identify® Diagnostics Drug Test Cups
Version or Model: ID-CP12-BUP-AZ2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ID-CP12-BUP-AZ2
Company Name: MEDICAL DISTRIBUTION GROUP INC

Primary DI Number: 10850013035219
Issuing Agency: GS1
Commercial Distribution End Date: November 03, 2033
Device Count: 2
Labeler D-U-N-S® Number*: 064177324 *Terms of Use

Device Description: Identify Diagnostics Drug Test Cups CLIA WAIVED For In Vitro Diagnostics Use Only 12 Panel Configuration AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, PCP25, OXY100, THC50 Contents: Test Cups - 2, PI - 1, Security Seals - 2

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DJR	Enzyme Immunoassay, Methadone
DIS	Enzyme Immunoassay, Barbiturate
JXM	Enzyme Immunoassay, Benzodiazepine
LCM	Enzyme Immunoassay, Phencyclidine
DJC	Thin Layer Chromatography, Methamphetamine
DKZ	Enzyme Immunoassay, Amphetamine
DJG	Enzyme Immunoassay, Opiates
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJ	Enzyme Immunoassay, Cannabinoids

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130463	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3766369d-5aba-4716-836e-fae65923656e
Public Version Date: January 28, 2025
Public Version Number: 3
DI Record Publish Date: November 15, 2023